Cleared Traditional

TECHFIT DISRP? System

K230276 · Techfit Digital Surgery · Dental
Jun 2023
Decision
142d
Days
Class 2
Risk

About This 510(k) Submission

K230276 is an FDA 510(k) clearance for the TECHFIT DISRP? System, a Driver, Wire, And Bone Drill, Manual (Class II — Special Controls, product code DZJ), submitted by Techfit Digital Surgery (Daytona Beach, US). The FDA issued a Cleared decision on June 23, 2023, 142 days after receiving the submission on February 1, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.4120.

Submission Details

510(k) Number K230276 FDA.gov
FDA Decision Cleared SESE
Date Received February 01, 2023
Decision Date June 23, 2023
Days to Decision 142 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code DZJ — Driver, Wire, And Bone Drill, Manual
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.4120